Investigator’s Brochure (IB) Translations

CSOFT Health Sciences offers high quality investigator’s brochure translations to facilitate success in the global clinical trials market.

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Home 9 Investigator’s Brochure (IB) Translations
With more than 50% of all clinical trials being conducted overseas, investigator’s brochure (IB) translations are an essential multilingual communications asset and are necessary for regulatory compliance. While trial sponsors are responsible for high volumes of documentation throughout all clinical trial phases, the investigator’s brochure (IB) is one of the most important documents and functions primarily to assess the benefits and risks of the investigational product (IP) being studied. The investigator’s brochure (IB) also details information like the chemical, physical, pharmaceutical properties, and formulas of the IP, as well as any side effects and the safety measures outlined in the study protocol. For both clinical and non-clinical studies, the investigator’s brochure (IB) must be presented to investigators, often times in the languages of the country where the trial is being conducted. To hep sponsors and other stakeholders throughout the clinical trials process, CSOFT Health Sciences offers investigator’s brochure (IB) translations with fast turn around times, in 250+ languages.

Quality Assurance

Through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.

Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.

Learn more about how CSOFT protects companies’ data.

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